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Clinical Trial Results:
A Phase 2b Trial of SB-061 for the Treatment of Symptomatic Osteoarthritis of the Knee

Summary
EudraCT number	2019-004515-31
Trial protocol	DK
Global end of trial date	07 Oct 2021

Results information
Results version number	v1(current)
This version publication date	22 Jun 2023
First version publication date	22 Jun 2023
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

TP-1879

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Nordic Bioscience Clinical Development

Sponsor organisation address

Telefonvej 8d, Søborg, Denmark, 2860

Public contact

Regulatory Affairs Department, Nordic Bioscience CLinical Development, +45 73707908, regulatory@nbcd.com

Scientific contact

Regulatory Affairs Department, Nordic Bioscience CLinical Development, +45 73707908, regulatory@nbcd.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

09 Dec 2021

Is this the analysis of the primary completion data?

Yes

Primary completion date

07 Oct 2021

Global end of trial reached?

Yes

Global end of trial date

07 Oct 2021

Was the trial ended prematurely?

Main objective of the trial

To evaluate the efficacy of SB-061 administered via intra-articular injection to reduce pain in subjects with symptomatic osteoarthritis of the knee.

Protection of trial subjects

Patient protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations. To manage pain, subject were provided with rescue pain medication in the form of paracetamol tablets 500 mg. The dosage of paracetamol that the subjects was allowed to take per day was defined according to the standard of care in the countries where the trial was carried out; however, the maximum dose should not exceed 1 gram per dose and 4 grams per day.

Background therapy

N/A

Evidence for comparator

N/A

Actual start date of recruitment

03 Feb 2020

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Denmark: 250

Country: Number of subjects enrolled

Hong Kong: 36

Worldwide total number of subjects

286

EEA total number of subjects

250

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

188

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

First Subject First Visit was on 04 February 2020 Last Subject Fist Visit was on 07 October 2021

Screening details

Overall 846 subjects were screened in this study, out of which 286 subjects were randomized and received the study treatment into the study.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Carer, Assessor

Are arms mutually exclusive

Yes

SB-061

Arm description

Arm type

Experimental

Investigational medicinal product name

SB-061

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Intraarticular use

Dosage and administration details

Treatment period of 32 weeks, with 3 single injections of 30 mg SB-061 performed on Day 1, on Day 113 and on Day 225, respectively

Placebo

Arm description

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Intraarticular use

Dosage and administration details

Treatment period of 32 weeks, with 3 single injections of Sterile isotonic saline (solution of 0.90% w/v of NaCl) performed on Day 1, on Day 113 and on Day 225, respectively

Number of subjects in period 1	SB-061	Placebo
Started	145	141
Completed	129	125
Not completed	16	16
Consent withdrawn by subject	1	5
Adverse event, non-fatal	7	4
Lost to follow-up	3	3
Protocol deviation	2	2
Lack of efficacy	3	2

Baseline characteristics

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Reporting group title

SB-061

Reporting group description

Reporting group title

Placebo

Reporting group description

Reporting group values	SB-061	Placebo	Total
Number of subjects	145	141	286
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	98	90	188
From 65-84 years	47	51	98
85 years and over	0	0	0
Gender categorical
Units: Subjects
Female	89	87	176
Male	56	54	110
Race
Units: Subjects
American Indian or Alaska Native	0	0	0
Asian	19	17	36
Black or African American	0	2	2
Native Hawaiian or other Pacific Islander	0	0	0
White	126	122	248
Other	0	0	0
Ethnicity
Units: Subjects
Hispanic or latino	0	0	0
Not hispanic or latino	145	141	286
Unknown	0	0	0

End points

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Reporting group title

SB-061

Reporting group description

Reporting group title

Placebo

Reporting group description

Primary: The change from baseline in reported pain as measured by the WOMAC A 11-point NRS 3.1 (5 questions) in the target knee at Week 8 of the trial.

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End point title

The change from baseline in reported pain as measured by the WOMAC A 11-point NRS 3.1 (5 questions) in the target knee at Week 8 of the trial.

End point description

End point type

Primary

End point timeframe

From baseline to Week 8 of the trial.

End point values	SB-061	Placebo
Number of subjects analysed	141	137
Units: Score
least squares mean (standard deviation)	-13.3 ± 17.21	-13.9 ± 18.9

Change in WOMAC pain sub-score at week 8

Statistical analysis description

The treatment effect on the primary endpoint was assessed using a repeated measurement analysis of variance (MMRM) on absolute change from baseline, including baseline value, the treatment group, the time point, sex, country, the subject characteristic of unilateral/bilateral knee OA at baseline as factors, and including treatment by time as interaction.

Comparison groups

Placebo v SB-061

Number of subjects included in analysis

278

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.05

Method

Mixed models analysis

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Adverse events

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Timeframe for reporting adverse events

The AE reporting period for safety surveillance begins when subject is initially included in the trial (date of first signature of informed consent/date of first signature of first informed consent) until end of study

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

23.0

Reporting group title

SB-061

Reporting group description

Reporting group title

Placebo

Reporting group description

Serious adverse events	SB-061	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	8 / 145 (5.52%)	12 / 141 (8.51%)
number of deaths (all causes)	0	1
number of deaths resulting from adverse events	0	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
subjects affected / exposed	1 / 145 (0.69%)	0 / 141 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Iris melanoma
subjects affected / exposed	1 / 145 (0.69%)	0 / 141 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Melanocytic naevus
subjects affected / exposed	0 / 145 (0.00%)	1 / 141 (0.71%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Myocardial infarction
subjects affected / exposed	1 / 145 (0.69%)	0 / 141 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Knee arthroplasty
subjects affected / exposed	1 / 145 (0.69%)	0 / 141 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Sciatica
subjects affected / exposed	0 / 145 (0.00%)	1 / 141 (0.71%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	1 / 145 (0.69%)	1 / 141 (0.71%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Gastrooesophageal reflux disease
subjects affected / exposed	1 / 145 (0.69%)	0 / 141 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Bile duct stone
subjects affected / exposed	0 / 145 (0.00%)	1 / 141 (0.71%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	0 / 145 (0.00%)	1 / 141 (0.71%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	0 / 145 (0.00%)	1 / 141 (0.71%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
subjects affected / exposed	0 / 145 (0.00%)	1 / 141 (0.71%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Renal and urinary disorders
Nephrolithiasis
subjects affected / exposed	0 / 145 (0.00%)	1 / 141 (0.71%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ureterolithiasis
subjects affected / exposed	0 / 145 (0.00%)	1 / 141 (0.71%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Osteoarthritis
subjects affected / exposed	0 / 145 (0.00%)	2 / 141 (1.42%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arthralgia
subjects affected / exposed	1 / 145 (0.69%)	0 / 141 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	1 / 145 (0.69%)	0 / 141 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Abdominal infection
subjects affected / exposed	1 / 145 (0.69%)	0 / 141 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis
subjects affected / exposed	0 / 145 (0.00%)	1 / 141 (0.71%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	0 / 145 (0.00%)	1 / 141 (0.71%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	SB-061	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	116 / 145 (80.00%)	120 / 141 (85.11%)
Injury, poisoning and procedural complications
Procedural pain
subjects affected / exposed	6 / 145 (4.14%)	8 / 141 (5.67%)
occurrences all number	7	9
Nervous system disorders
Headache
subjects affected / exposed	32 / 145 (22.07%)	15 / 141 (10.64%)
occurrences all number	58	27
General disorders and administration site conditions
Influenza like illness
subjects affected / exposed	10 / 145 (6.90%)	4 / 141 (2.84%)
occurrences all number	10	4
Injection site joint pain
subjects affected / exposed	4 / 145 (2.76%)	7 / 141 (4.96%)
occurrences all number	5	7
Gastrointestinal disorders
Toothache
subjects affected / exposed	12 / 145 (8.28%)	10 / 141 (7.09%)
occurrences all number	13	12
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	37 / 145 (25.52%)	37 / 141 (26.24%)
occurrences all number	54	45
Back pain
subjects affected / exposed	21 / 145 (14.48%)	18 / 141 (12.77%)
occurrences all number	30	23
Pain in extremity
subjects affected / exposed	7 / 145 (4.83%)	17 / 141 (12.06%)
occurrences all number	10	24
Neck pain
subjects affected / exposed	10 / 145 (6.90%)	6 / 141 (4.26%)
occurrences all number	10	9
Infections and infestations
Nasopharyngitis
subjects affected / exposed	10 / 145 (6.90%)	9 / 141 (6.38%)
occurrences all number	11	9
Cystitis
subjects affected / exposed	4 / 145 (2.76%)	7 / 141 (4.96%)
occurrences all number	4	10

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
A Phase 2b Trial of SB-061 for the Treatment of Symptomatic Osteoarthritis of the Knee

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: The change from baseline in reported pain as measured by the WOMAC A 11-point NRS 3.1 (5 questions) in the target knee at Week 8 of the trial.

Primary: The change from baseline in reported pain as measured by the WOMAC A 11-point NRS 3.1 (5 questions) in the target knee at Week 8 of the trial.

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Clinical trials

Clinical Trial Results: A Phase 2b Trial of SB-061 for the Treatment of Symptomatic Osteoarthritis of the Knee

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: The change from baseline in reported pain as measured by the WOMAC A 11-point NRS 3.1 (5 questions) in the target knee at Week 8 of the trial.

Primary: The change from baseline in reported pain as measured by the WOMAC A 11-point NRS 3.1 (5 questions) in the target knee at Week 8 of the trial.

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 2b Trial of SB-061 for the Treatment of Symptomatic Osteoarthritis of the Knee